Purdue Pharma’s $7.4 Billion Chapter 11 Plan Formally Approved
Eric Furman, Ph.D. & Rhett D. Ramsey
A federal bankruptcy court on November 18 formally approved Purdue’s $7.4 billion Chapter 11 plan to settle thousands of opioid-related lawsuits. The plan requires (1) a $6.5 billion contribution from the Sackler family members who own Purdue and (2) a $900 million contribution from Purdue itself. The contributions will be placed into disbursement trusts to provide recoveries to individual personal injury claimants and state and local governments and agencies with claims tied to the national opioid epidemic.
Patent Exclusivity and Price Controls: Teva v. Kennedy
Jane Dai, Ph.D. & Alistair J. McIntyre
On November 20, 2025, the D.C. District Court issued its opinion [1] in a lawsuit where Teva Pharmaceuticals USA, Inc. challenged the validity of the Medicare Drug Price Negotiation Program under the Inflation Reduction Act of 2022 (IRA). The opinion sheds light on how exclusivity under patent law intersects with the price controls of the Drug Negotiation Program. The opinion also underscores that patent rights exist within a regulatory framework where Congress and federal agencies like the Centers for Medicare & Medicaid Services (CMS) and Food and Drug Administration (FDA) can alter the commercial value of exclusivity conferred by patent rights.
USPTO’s Automated Search Pilot: Through a Biotech Lens
Jason J. Jardine and Geetha Durairaj, Ph.D.
In October 2025, the U.S. Patent and Trademark Office (USPTO) launched the “Artificial Intelligence Search Automated Pilot Program,” or ASAP!, an initiative to identify potential prior art using artificial intelligence (AI) tools before a patent application is examined. Original, noncontinuing, nonprovisional utility applications filed under 35 U.S.C. 111(a) on or after October 20, 2025, and on or before April 20, 2026 are eligible to participate in ASAP!.
Life Science Considerations on the USPTO’s New Guidelines for AI-Assisted Inventorship
Robert J. Hilton, Ph.D. & Susan M. Janicki, Ph.D.
On November 26, 2025, the United States Patent and Trademark Office (USPTO) issued revised guidelines for determining inventorship of AI-assisted inventions,[1] which is a significant development in life science innovations, which increasingly rely on computational and AI-driven tools. The USPTO rescinded its earlier guidance[2], which suggested applying the Pannu factors[3] for determining joint inventorship to the determination of whether a single person using an AI system is an inventor. The new guidance emphasizes that the touchstone of inventorship remains “conception,” the formation in the mind of the inventor of a definite and permanent idea of the complete and operative invention.
Proposed Legislation to Codify “Skinny Label” Safe Harbor
On December 5, 2025, the Skinny Labels, Big Savings Act (H.R. 6485) was introduced in the House of Representatives. The bill, if enacted, would shield certain drug manufacturers who have submitted drug applications to the Food and Drug Administration (“FDA”) from patent infringement liability, including induced and contributory infringement, based on those submissions and commercial marketing of the approved drug.[1] The safe harbor for drugs in the proposed legislation is limited to infringement claims based on method-of-use patents listed in the FDA’s Orange Book, which relates to drugs for human use, or the Agency’s Green Book, which relates to drugs for animal use.
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